A phase IV clinical trial to assess the safety and tolerability of Darunavir 800mg tablets once daily in HIV 1 infection

A Phase IV, Open Label, Non-Comparative, Multicenter study to access Safety and Tolerability of Darunavir Ethanolate 800mg tablets once daily co-administered with Ritonavir 100mg tablets once daily and other Anti-Retroviral agents in adults subjects with Human Immunodeficiency Virus (HIV-1) infection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/014117

Enrollment

167

Registered

2018-05-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B20- Human immunodeficiency virus [HIV]disease

Interventions

Intervention1: Darunavir Ethanolate 800mg: Darunavir Ethanolate 800mg tablets once daily co-administered with Ritonavir 100mg tablets once daily and other Anti-Retroviral agents Study duration: 12 m

Eligibility

Inclusion criteria

Inclusion criteria: 1. Audio consent and a written signed dated informed consent from subjects and/or legally acceptable representative 2. Either gender with age 18 years and above 3. Subjects with human immunodeficiency virus (HIV -1) infection who are treatment-experienced adult patients with no Darunavir resistance associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V)

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to Darunavir Ethanolate or Ritonavir or any of its components or other anti-retroviral agents given concomitantly 2. Subjects with sulfa allergy 3. Pregnancy or breastfeeding 4. Severe Hepatic Impairment Child Pugh Class C 5. Concomitant use of drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index) 6. Subject unsuitable to participate in the study as per the discretion of investigator

Design outcomes

Primary

Measure	Time frame
To assess safety and tolerability of Darunavir Ethanolate 800mg tablets once daily co-administered with Ritonavir 100mg tablets once daily and other anti-retroviral agents in adult subjects with HIV-1 infection.Timepoint: Visit 1- Screening visit Visit 2- Baseline Visit Visit 3- Week 12 Visit 4- Week 24	—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactDr Yashesh Mehta

Cipla Ltd.

sandesh.sawant3@cipla.com02223025194

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026